Non-small Cell Lung Cancer (NSCLC)salVageNCT06114108
Trial Comparing Systemic Therapy Alone and With Local Ablative Treatment for Stage IV NSCL Cancer Patients
A study testing Systemic therapy alone or in combination with LAT (surgery and/or radiotherapy), Surgery and Radiotherapy in people with Non-small Cell Lung Cancer (NSCLC) and Stage IV, run by Swiss Cancer Institute at 7 sites in Switzerland.
Trial summary
Unfortunately, most patients are already at a very advanced stage when they are diagnosed with lung cancer, i.e. the cancer has already spread outside the lungs forming metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC), Stage IV
- What is being tested?
- Systemic therapy alone or in combination with LAT (surgery and/or radiotherapy), Surgery and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 7 sitesSwitzerland
- Study dates
- 21 Dec 2023to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients fulfilling all of the following inclusion criteria at screening may be enrolled in the trial.
- The inclusion criteria are irrespective from the tumor burden at the time of primary diagnosis before initiation of first line systemic therapy. Treatment of brain metastases upfront or after an induction phase of standard systemic therapy is done according to the standard practice of the treating center.
- Adults (18 years or older)
- Tissue confirmed, pre-treatment clinical stage IV NSCLC
- ECOG performance status ≤ 1
- Patients responding after 3 cycles (4th bridging cycle up until randomization is allowed) or 3 months of first line SoC systemic therapy with PR or SD in restaging imaging, and presenting with (induced) oligometastatic or oligopersistent NSCLC defined as a maximum of 5 residual extracranial, distant metastases
Show all 10Show fewer
- Patients may have up to 5 cranial metastases in addition to the oligoresidual extracranial metastases as long as they are amenable for radiotherapy or surgery.
- The primary tumor and all oligopersistent metastases must be amenable for radical LAT (surgery or radiotherapy)
- Patients of reproductive age agree to use double contraception during the study
- Patient is able to understand trial procedures and is able/willing to adhere to trial procedures as confirmed by signature
Who cannot join
- The presence of any one of the following exclusion criteria at screening will lead to exclusion of the participant:
- Serious concomitant disorder that would compromise patient safety during LAT
- Unresolved complications from initial systemic anticancer treatment, higher than CTCAE grade 2
- Metastatic locations such as malignant ascites, malignant pleural or malignant pericardial effusion, diffuse lymphangiosis of skin or lung, diffuse bone marrow metastasis, abdominal masses/abdominal organomegaly, identified by physical exam that is not measurable by reproducible imaging techniques, leptomeningeal carcinomatosis
- Women who are pregnant or breast feeding
- Patient is currently involved in a trial that either does not permit participation in other trials or would result in excessive patient burden if another trial were joined. In such cases, the co-investigators' team and the Patient Advisory Board will decide on participation on an individual basis.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Switzerland7 sites, 7 recruiting
- Recruiting
Kantonspital Aarau
Aarau, 5001
Max Lacour, MD, +41 62 838 45 10, max.lacour@ksa.ch
Max Lacour, MD
- Recruiting
IOSI Ospedale Regionale di Bellinzona e Valli
Bellinzona, 6500
Patrizia Froesch, MD, +41 91 811 48 40, patrizia.froesch@eoc.ch
Patrizia Froesch, MD
- Recruiting
Kantonsspital Graubuenden
Chur, CH-7000
Michael Thomas Mark, MD, +41 (0)81 256 61 11, michael.mark@ksgr.ch
Michael Thomas Mark, MD
- Recruiting
Hôpital Fribourgeois - Hôpital Cantonal
Fribourg
Alessandra Curioni-Fontecedro, Prof, +41 26 306 22 60, alessandra.curioni-fontecedro@h-fr.ch
Alessandra Curioni-Fontecedro, Prof
- Recruiting
Hôpitaux Universitaires Genève HUG
Geneva, 1205
Benoît Bédat, MD, +41 22 372 78 84, benoit.bedat@hcuge.ch
Benoît Bédat, MD
- Recruiting
Luzerner Kantonsspital
Lucerne
Fabrizio Minervini, MD, +41 41 205 45 01, fabrizio.minervini@luks.ch
Fabrizio Minervini, MD
- Recruiting
Universitätsspital Zürich
Zurich, 8091
Isabelle Schmitt-Opitz, Prof, +41 44 255 92 99, isabelle.schmitt-opitz@usz.ch
Isabelle Schmitt-Opitz, Prof
About this study
Official title: Phase III Randomized Controlled Trial Comparing Maintenance Systemic Therapy Alone With Systemic Therapy Plus Local Ablative Treatment for Patients With Advanced Stage IV Non-small Cell Lung Cancer
Unfortunately, most patients are already at a very advanced stage when they are diagnosed with lung cancer, i.e. the cancer has already spread outside the lungs forming metastases. The current standard of care therapy at this advanced stage of lung cancer includes systemic anti-cancer therapy such as chemotherapy, immunotherapy to boost the body's immune response, or targeted therapy that directly hinders tumor growth. In this study, the aim is to find out whether it is better if, after a good response to the standard therapy, the remains of main tumor and the metastases are additionally treated by surgery and/or radiation.
Read the detailed description
In this study, the aim is to find out whether, after a good response to standard therapy, it is better if the main tumor and metastases are additionally removed by surgery and/or radiation. This intervention is referred to as local ablative therapy (LAT). There is evidence to suggest that this additional intervention may prolong the average time to possible cancer recurrence (PFS: Progression-free survival) or lead to longer survival on average. Therefore, the question is to know if these treatments prolong life, and if so, by how much and with what implications. Currently, patients who respond to initial standard therapy are not routinely offered LAT. If the results of this study are positive, it will lead to a fundamental change in the current standard of practice.
The benefit of a therapy is not solely determined by the extension of PFS or overall survival but also heavily influenced by how the therapy impacts patient's quality of life. Medication side effects, pain, fatigue, nausea or extended hospital stays can significantly diminish the perceived positive effects of a treatment from the patient's viewpoint, even if it appears favorable from a medical standpoint. Therefore, the assessment of quality of life through patient-reported outcome measures (PROMs) is a central aspect of this study.
This study will enroll 128 patients from different Swiss hospitals, randomly assigning them to either the intervention group (LAT) or a control group (standard therapy). The study is expected to span approximately two years for each patient.
- Conditions
- Non-small Cell Lung Cancer (NSCLC), Stage IV
- Being tested
- Systemic therapy alone or in combination with LAT (surgery and/or radiotherapy), Surgery, Radiotherapy
- Keywords
- Non-small cell lung cancer (NSCLC), Local consolidative treatment (LAT), patient-reported outcome measures (PROMs)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic therapy alone or in combination with LAT (surgery and/or radiotherapy)Other
Also called Systemic therapy
The choice of LAT intervention for the primary tumor and all metastases (surgery or SBRT) and the sequence of the treatment (primary tumor vs metastases) will be decided at the local MDT according to the medical need and patient counseling during interdisciplinary clinic visits.
SurgeryOther
Surgery
RadiotherapyRadiation
Radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: Local consolidative treatment (LAT) & Systemic Therapy | Experimental | All patients undergo standard of care (SoC) first-line systemic therapy according to the results of the molecular analysis obtained from the diagnostic biopsy, as per standard of the respective center.
Patients will undergo additional complete surgical resection of the primary tumor with mediastinal lymph node sampling or radical radiotherapy (preferred stereotactic body radiotherapy (SBRT) to the primary tumor. Surgery and/or SBRT to the metastases will be performed before or after the treatment of the primary tumor according to the clinical need. Thereafter, the treatment will be followed by systemic anticancer treatment as SoC. Receives: Other: Systemic therapy alone or in combination with LAT (surgery and/or radiotherapy); Other: Surgery; Radiation: Radiotherapy |
| Control group: Systemic Therapy | Active comparator | Patients of the control group will receive systemic anticancer treatment alone chemotherapy, chemo-immunotherapy, immunotherapy alone, or targeted treatment). Receives: Other: Systemic therapy alone or in combination with LAT (surgery and/or radiotherapy); Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) l in the Local Ablative Therapy (LAT) arm is superior to Standard of Care (SoC)
Progression free survival (PFS) will be assessed by regular clinical examinations of the patients and based on imaging modalities such as (PET)-CT scans and brain MRIs.
Measured: up to 24 months after randomization
Quality of life (QoL) in the LAT arm is non-inferior to the control arm as measured with the European Quality of Life 5 Dimensions 3 Level (EQ-5D-5L) questionnaire-based score at 6 months after randomization
To show that QoL in the LAT arm is non-inferior to the control arm, mobility the European Quality of Life 5 Dimensions 3 Level (EQ-5D-5L) questionnaire will be used. The questionnaire uses an 1 (no problem) to 5 (extreme problems) scale.
Measured: 6 months after randomization
Secondary outcomes (5)
Patients undergoing LAT maintain Quality of Life (QoL)
Patients undergoing LAT maintain Quality of Life (QoL) as measured by using the EQ-5D-5L on different time points of the trial.
Measured: up to 24 months after randomization
To assess safety and tolerability of the LAT strategy as compared to standard of care
Safety to study interventions will be evaluated by measuring counts of serious adverse events from randomization until 30 days after last intervention or progression, whichever occurs first. Serious adverse events will be evaluated based on CTCAE v5.0.from randomization up until 30 days after last intervention.
Measured: from randomization until 30 days after last intervention
To compare quality-adjusted life years
Quality-adjusted life years will be calculated based on the EQ-5D-5L scores and compared between treatment groups, as accrued during the trial observation period across all time points
Measured: up to 24 months after randomization
To evaluate the economic impact of the LAT approach
The economic impact of the LAT approach will be calculated based on the costs of the LAT intervention and on the costs of healthcare utilization outside of the hospital. For the calculation of healthcare utilization costs, patients will be asked on scheduled visits about the healthcare services they have been using outside of the hospital.
Measured: from signing informed consent until 24 months after randomization
To assess the response of primary tumor and metastases to systemic treatment alone and in combination with LAT (according to (i)RECIST criteria)
Measured: from intervention until 24 month after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start21 Dec 2023
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, open label, randomized, controlled, international, multicenter interventional clinical trial
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Schmitt-Opitz, Prof, Study director, Universitätsspital Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114108
- Sponsor's protocol ID
- salVage
- Acronym
- salVage
- Status last verified
- Mar 2026
- First submitted
- 22 Sep 2023
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Controlled Trial Comparing Maintenance Systemic Therapy Alone With Systemic Therapy Plus Local Ablative Treatment for Patients With Advanced Stage IV Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06114108
- Acronym / sponsor ID
- salVage / salVage
- Conditions
- Non-small Cell Lung Cancer (NSCLC), Stage IV
- Keywords
- Non-small cell lung cancer (NSCLC), Local consolidative treatment (LAT), patient-reported outcome measures (PROMs)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Swiss Cancer InstituteUniversity, hospital or other
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Unfortunately, most patients are already at a very advanced stage when they are diagnosed with lung cancer, i.e. the cancer has already spread outside the lungs forming metastases. The current standard of care therapy at this advanced stage of lung cancer includes systemic anti-cancer therapy such as chemotherapy, immunotherapy to boost the body's immune response, or targeted therapy that directly hinders tumor growth. In this study, the aim is to find out whether it is better if, after a good response to the standard therapy, the remains of main tumor and the metastases are additionally treated by surgery and/or radiation.
Detailed description
In this study, the aim is to find out whether, after a good response to standard therapy, it is better if the main tumor and metastases are additionally removed by surgery and/or radiation. This intervention is referred to as local ablative therapy (LAT). There is evidence to suggest that this additional intervention may prolong the average time to possible cancer recurrence (PFS: Progression-free survival) or lead to longer survival on average. Therefore, the question is to know if these treatments prolong life, and if so, by how much and with what implications. Currently, patients who respond to initial standard therapy are not routinely offered LAT. If the results of this study are positive, it will lead to a fundamental change in the current standard of practice.
The benefit of a therapy is not solely determined by the extension of PFS or overall survival but also heavily influenced by how the therapy impacts patient's quality of life. Medication side effects, pain, fatigue, nausea or extended hospital stays can significantly diminish the perceived positive effects of a treatment from the patient's viewpoint, even if it appears favorable from a medical standpoint. Therefore, the assessment of quality of life through patient-reported outcome measures (PROMs) is a central aspect of this study.
This study will enroll 128 patients from different Swiss hospitals, randomly assigning them to either the intervention group (LAT) or a control group (standard therapy). The study is expected to span approximately two years for each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, open label, randomized, controlled, international, multicenter interventional clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group: Local consolidative treatment (LAT) & Systemic Therapy | Experimental | Other: Systemic therapy alone or in combination with LAT (surgery and/or radiotherapy), Other: Surgery, Radiation: RadiotherapyAll patients undergo standard of care (SoC) first-line systemic therapy according to the results of the molecular analysis obtained from the diagnostic biopsy, as per standard of the respective center. Patients will undergo additional complete surgical resection of the primary tumor with mediastinal lymph node sampling or radical radiotherapy (preferred stereotactic body radiotherapy (SBRT) to the primary tumor. Surgery and/or SBRT to the metastases will be performed before or after the treatment of the primary tumor according to the clinical need. Thereafter, the treatment will be followed by systemic anticancer treatment as SoC. |
| Control group: Systemic Therapy | Active comparator | Other: Systemic therapy alone or in combination with LAT (surgery and/or radiotherapy), Radiation: RadiotherapyPatients of the control group will receive systemic anticancer treatment alone chemotherapy, chemo-immunotherapy, immunotherapy alone, or targeted treatment). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients fulfilling all of the following inclusion criteria at screening may be enrolled in the trial.
- The inclusion criteria are irrespective from the tumor burden at the time of primary diagnosis before initiation of first line systemic therapy. Treatment of brain metastases upfront or after an induction phase of standard systemic therapy is done according to the standard practice of the treating center.
- Adults (18 years or older)
- Tissue confirmed, pre-treatment clinical stage IV NSCLC
- ECOG performance status ≤ 1
Key exclusion criteria (6 listed)
- The presence of any one of the following exclusion criteria at screening will lead to exclusion of the participant:
- Serious concomitant disorder that would compromise patient safety during LAT
- Unresolved complications from initial systemic anticancer treatment, higher than CTCAE grade 2
- Metastatic locations such as malignant ascites, malignant pleural or malignant pericardial effusion, diffuse lymphangiosis of skin or lung, diffuse bone marrow metastasis, abdominal masses/abdominal organomegaly, identified by physical exam that is not measurable by reproducible imaging techniques, leptomeningeal carcinomatosis
- Women who are pregnant or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systemic therapy alone or in combination with LAT (surgery and/or radiotherapy)Also: Systemic therapyThe choice of LAT intervention for the primary tumor and all metastases (surgery or SBRT) and the sequence of the treatment (primary tumor vs metastases) will be decided at the local MDT according to the medical need and patient counseling during interdisciplinary clinic visits. | Other | Control group: Systemic Therapy, Intervention group: Local consolidative treatment (LAT) & Systemic Therapy |
| SurgerySurgery | Other | Intervention group: Local consolidative treatment (LAT) & Systemic Therapy |
| RadiotherapyRadiotherapy | Radiation | Control group: Systemic Therapy, Intervention group: Local consolidative treatment (LAT) & Systemic Therapy |
Primary outcome
Progression-Free Survival (PFS) l in the Local Ablative Therapy (LAT) arm is superior to Standard of Care (SoC)
Time frame: up to 24 months after randomization
Progression free survival (PFS) will be assessed by regular clinical examinations of the patients and based on imaging modalities such as (PET)-CT scans and brain MRIs.
Quality of life (QoL) in the LAT arm is non-inferior to the control arm as measured with the European Quality of Life 5 Dimensions 3 Level (EQ-5D-5L) questionnaire-based score at 6 months after randomization
Time frame: 6 months after randomization
To show that QoL in the LAT arm is non-inferior to the control arm, mobility the European Quality of Life 5 Dimensions 3 Level (EQ-5D-5L) questionnaire will be used. The questionnaire uses an 1 (no problem) to 5 (extreme problems) scale.
5 secondary outcomes
Patients undergoing LAT maintain Quality of Life (QoL)
Time frame: up to 24 months after randomization
To assess safety and tolerability of the LAT strategy as compared to standard of care
Time frame: from randomization until 30 days after last intervention
To compare quality-adjusted life years
Time frame: up to 24 months after randomization
To evaluate the economic impact of the LAT approach
Time frame: from signing informed consent until 24 months after randomization
To assess the response of primary tumor and metastases to systemic treatment alone and in combination with LAT (according to (i)RECIST criteria)
Time frame: from intervention until 24 month after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isabelle Schmitt-Opitz, Prof study director
Universitätsspital Zürich
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systemic therapy alone or in combination with LAT (surgery and/or radiotherapy), Surgery and Radiotherapy in people with Non-small Cell Lung Cancer (NSCLC) and Stage IV, run by Swiss Cancer Institute at 7 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gwendoline Wicki (+41 31 389 91 91, trials@swisscancerinstitute.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) l in the Local Ablative Therapy (LAT) arm is superior to Standard of Care (SoC) (time frame: up to 24 months after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.